Haemophilus Influenzae Type b, Neisseria Meningitidis
Conditions
Keywords
Invasive bacterial disease caused by Hib, Neisseria meningitidis serogroups C & Y
Brief summary
This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed meningococcal serogroup C conjugate vaccine, each administered at 2, 3, and 4 months of age. Antibody persistence and immune responses to booster vaccinations were additionally assessed at 12 to 18 months of age.
Detailed description
Primary & booster vaccination study to evaluate the immuno,reacto & safety of 3 diff. formulations of GSKBio'combined Haemophilus influenzae typeb-meningococcal serogroups C & Y-conjugate vaccine & one formulation of GSKBio' Haemophilus influenzae typeb-meningococcal serogroup C conjugate vaccine each given concomitantly With Infanrix penta (DTaP-IPV-HepB vaccine), vs Meningitec meningococcal SerogroupC conj.vaccine) given concomitantly With Infanrix hexa (DTaP-IPV-HepB-Hib vaccine) in infants according a 2-3-4 mth schedule
Interventions
BIOLOGICALHib-MenCY-TT vaccine
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
BIOLOGICALHib-MenC-TT vaccine
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
BIOLOGICALMenjugate ®
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
BIOLOGICALInfanrix penta ®
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
BIOLOGICALInfanrix hexa ®
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Healthy infants without major congenital illness, immunosuppression, or chronic disease born at 36 to 42 weeks of gestation, between 6 and 12 weeks of age at enrollment, and vaccinated against hepatitis B at birth.
Exclusion criteria
* Infants should not have received any investigational drug, vaccine, chronic immunosuppressants, or immunoglobulin or blood products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 | One month after dose 3 (at study Month 3 - primary phase) | rSBA-MenC antibody titre cut-off value assessed was ≥1:8 |
| Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). | One month after dose 3 (at study Month 3 - primary phase) | Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL) |
| Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 | One month after dose 3 (at study Month 3 - primary phase) | rSBA-MenY antibody titre cut-off value assessed was ≥1:8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). | Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase) | Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL) |
| rSBA-MenC Antibody Titres | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) | Titres are expressed as geometric mean titres (GMTs) |
| rSBA-MenY Antibody Titres | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) | Titres are expressed as geometric mean titres (GMTs) |
| Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) | Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL) |
| Anti-PRP Antibody Concentrations | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) | Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL. |
| Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) | Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL |
| Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) | Anti-PSY antibody concentration cut-off value assessed was ≥0.30 µg/mL |
| Anti-PSC Antibody Concentrations | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) | Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL. |
| Anti-PSY Antibody Concentrations | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) | Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL. |
| Anti-tetanus Antibody Concentrations | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) | Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL). |
| Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) | Antibody concentrations are expressed as geometric mean concentrations (GMCs) in Enzyme-Linked Immunosorbent Assay (ELISA) Units per millilitre. |
| Number of Seroprotected Subjects for Anti-tetanus Antibodies | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) | Seroprotection status is defined as anti-tetanus toxoid antibody concentration ≥ 0.1 International Units per millilitre (IU/mL) |
| Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) | Anti-FHA, anti-PRN and anti-PT antibody concentration cut-off value assessed was ≥ 5 ELISA units per millilitre. |
| Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128 | Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) | rSBA-MenC antibody titre cut-off value assessed was ≥1:128 |
| Number of Subjects With Solicited Local Symptoms | During the 8-day (Day 0-7) follow-up period (during the primary phase) | Solicited local symptoms assessed were pain, redness and swelling. |
| Number of Subjects With Solicited General Symptoms | During the 8-day (Day 0-7) follow-up period (during the primary phase) | Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)). |
| Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL) | Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) | Anti-PSC antibody concentration cut-off value assessed was ≥2.0 µg/mL |
| Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL). | Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) | Anti-tetanus toxoid antibody concentration cut-off value assessed was ≥ 0.1 IU/mL |
| Anti-T Antibody Concentrations | Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) | Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL). |
| Anti-diphtheria Antibody Concentrations | One month after the third dose (at study Month 3 - primary phase) | Antibody concentrations are expressed as geometric mean concentrations (GMCs) in IU/mL. |
| Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | One month after the third dose (at study Month 3 - primary phase) | Antibody concentrations are expressed as geometric mean concentrations (GMCs) in milli-International Units per millilitre (mIU/mL). |
| Anti-poliovirus Types 1, 2, 3 Antibody Titres | One month after the third dose (at study Month 3 - primary phase) | Titres are expressed as geometric mean titres (GMTs) |
| Number of Seroprotected Subjects for Anti-diphtheria Antibodies | One month after the third dose (at study Month 3 - primary phase) | Seroprotection status is defined as anti-diphtheria antibody concentrations ≥ 0.1 IU/mL |
| Number of Seroprotected Subjects for Anti-hepatitis B Antibodies | One month after the third dose (at study Month 3 - primary phase) | Seroprotection status is defined as anti-HBs antibody concentrations ≥ 10 mIU/mL |
| Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies | One month after the third dose (at study Month 3 - primary phase) | Seroprotection status is defined as anti-polio 1, 2 and 3 antibody titres ≥ 1:8 |
| Number of Subjects With Vaccine Response to PT, FHA and PRN | One month after the third dose (at study Month 3 - primary phase) | Vaccine response rates are defined as appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations \< cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 31-day (Day 0-30) follow-up period (during the primary phase) | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | Over the full course of the primary phase (up to study Month 3 - primary phase) | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. |
| Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128 | Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) | rSBA-MenY antibody titre cut-off value assessed was ≥1:128 |
| Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 | Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase) | rSBA-MenC antibody titre cut-off value assessed was ≥1:8 |
| Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 | Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase) | rSBA-MenY antibody titre cut-off value assessed was ≥1:8 |
Countries
Belgium, Germany
Participant flow
Pre-assignment details
The study is divided in two phases: * Primary phase: 3-dose primary vaccination at 2, 3 and 4 months of age = study Months 0, 1, 2. Data were collected up to 1 month after the 3rd dose (study Month 3) * Booster phase: booster dose at 12-18 months of age = study Month 0. Data were collected up to 1 month after the booster dose (study Month 1)
Participants by arm
| Arm | Count |
|---|---|
| Menhibrix F1/Infanrix-penta Group Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | 78 |
| Menhibrix F2/Infanrix-penta Group Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | 77 |
| Menhibrix F3/Infanrix-penta Group Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | 78 |
| Menitorix/Infanrix-penta Group Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | 78 |
| Menjugate/Infanrix-hexa Group Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | 77 |
| Total | 388 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Booster Phase | Lost to Follow-up | 2 | 0 | 0 | 0 | 1 |
| Primary Phase | Adverse Event | 1 | 1 | 0 | 0 | 0 |
| Primary Phase | Lost to Follow-up | 1 | 1 | 0 | 1 | 1 |
| Primary Phase | Other | 0 | 0 | 1 | 0 | 0 |
| Primary Phase | Protocol Violation | 0 | 1 | 0 | 0 | 0 |
| Primary Phase | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 8.5 Weeks STANDARD_DEVIATION 1.69 | 8.8 Weeks STANDARD_DEVIATION 1.72 | 8.7 Weeks STANDARD_DEVIATION 1.55 | 8.3 Weeks STANDARD_DEVIATION 1.63 | 9.0 Weeks STANDARD_DEVIATION 1.65 | 8.7 Weeks STANDARD_DEVIATION 1.65 |
| Sex: Female, Male Female | 31 Participants | 37 Participants | 44 Participants | 33 Participants | 40 Participants | 185 Participants |
| Sex: Female, Male Male | 47 Participants | 40 Participants | 34 Participants | 45 Participants | 37 Participants | 203 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 70 / 78 | 71 / 77 | 73 / 78 | 71 / 78 | 70 / 77 |
| serious Total, serious adverse events | 1 / 78 | 1 / 77 | 2 / 78 | 1 / 78 | 3 / 77 |
Outcome results
Primary
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
Time frame: One month after dose 3 (at study Month 3 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). | 66 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). | 66 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). | 69 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). | 73 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). | 57 Subjects |
Primary
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
Time frame: One month after the booster vaccination (at study Month 1 - booster phase)
Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). | 39 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). | 39 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). | 39 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). | 40 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). | 39 Subjects |
Primary
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
Time frame: One month after the booster vaccination (at study Month 1 - booster phase)
Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 | 40 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 | 39 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 | 42 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 | 41 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 | 39 Subjects |
Primary
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
Time frame: One month after dose 3 (at study Month 3 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 | 70 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 | 67 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 | 71 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 | 74 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 | 71 Subjects |
Primary
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
Time frame: One month after the booster vaccination (at study Month 1 - booster phase)
Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 | 40 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 | 39 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 | 42 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 | 13 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 | 14 Subjects |
Primary
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
Time frame: One month after dose 3 (at study Month 3 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 | 67 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 | 64 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 | 70 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 | 16 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 | 14 Subjects |
Secondary
Anti-diphtheria Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in IU/mL.
Time frame: One month after the third dose (at study Month 3 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Anti-diphtheria Antibody Concentrations | 1.016 IU/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-diphtheria Antibody Concentrations | 0.927 IU/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-diphtheria Antibody Concentrations | 0.980 IU/mL |
| Menitorix/Infanrix-penta Group | Anti-diphtheria Antibody Concentrations | 1.012 IU/mL |
| Menjugate/Infanrix-hexa Group | Anti-diphtheria Antibody Concentrations | 1.904 IU/mL |
Secondary
Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in Enzyme-Linked Immunosorbent Assay (ELISA) Units per millilitre.
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-PT [Month 0] (N=67,62,68,70,69) | 3.4 EL.U/mL |
| Menhibrix F1/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-PT [Month 3] (N=67,63,69,74,69) | 53.9 EL.U/mL |
| Menhibrix F1/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-FHA [Month 0] (N=69,63,69,72,70) | 6.5 EL.U/mL |
| Menhibrix F1/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-FHA [Month 3] (N=67,63,69,74,71) | 83.7 EL.U/mL |
| Menhibrix F1/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-PRN [Month 0] (N=68,62,71,72,70) | 6.3 EL.U/mL |
| Menhibrix F1/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-PRN [Month 3] (N=68,67,70,74,71) | 94.2 EL.U/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-FHA [Month 0] (N=69,63,69,72,70) | 6.0 EL.U/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-PT [Month 0] (N=67,62,68,70,69) | 3.1 EL.U/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-FHA [Month 3] (N=67,63,69,74,71) | 91.5 EL.U/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-PRN [Month 3] (N=68,67,70,74,71) | 97.1 EL.U/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-PRN [Month 0] (N=68,62,71,72,70) | 4.5 EL.U/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-PT [Month 3] (N=67,63,69,74,69) | 52.9 EL.U/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-FHA [Month 3] (N=67,63,69,74,71) | 89.3 EL.U/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-PT [Month 3] (N=67,63,69,74,69) | 50.8 EL.U/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-FHA [Month 0] (N=69,63,69,72,70) | 7.3 EL.U/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-PRN [Month 0] (N=68,62,71,72,70) | 5.5 EL.U/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-PRN [Month 3] (N=68,67,70,74,71) | 96.2 EL.U/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-PT [Month 0] (N=67,62,68,70,69) | 3.7 EL.U/mL |
| Menitorix/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-FHA [Month 3] (N=67,63,69,74,71) | 92.4 EL.U/mL |
| Menitorix/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-PT [Month 3] (N=67,63,69,74,69) | 55.4 EL.U/mL |
| Menitorix/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-PRN [Month 3] (N=68,67,70,74,71) | 99.1 EL.U/mL |
| Menitorix/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-PT [Month 0] (N=67,62,68,70,69) | 3.3 EL.U/mL |
| Menitorix/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-PRN [Month 0] (N=68,62,71,72,70) | 6.4 EL.U/mL |
| Menitorix/Infanrix-penta Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-FHA [Month 0] (N=69,63,69,72,70) | 9.9 EL.U/mL |
| Menjugate/Infanrix-hexa Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-PT [Month 0] (N=67,62,68,70,69) | 3.1 EL.U/mL |
| Menjugate/Infanrix-hexa Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-FHA [Month 3] (N=67,63,69,74,71) | 74.0 EL.U/mL |
| Menjugate/Infanrix-hexa Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-PRN [Month 0] (N=68,62,71,72,70) | 6.5 EL.U/mL |
| Menjugate/Infanrix-hexa Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-PT [Month 3] (N=67,63,69,74,69) | 41.3 EL.U/mL |
| Menjugate/Infanrix-hexa Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-PRN [Month 3] (N=68,67,70,74,71) | 80.2 EL.U/mL |
| Menjugate/Infanrix-hexa Group | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations | Anti-FHA [Month 0] (N=69,63,69,72,70) | 7.0 EL.U/mL |
Secondary
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in milli-International Units per millilitre (mIU/mL).
Time frame: One month after the third dose (at study Month 3 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | 377.9 mIU/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | 397.0 mIU/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | 408.9 mIU/mL |
| Menitorix/Infanrix-penta Group | Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | 520.5 mIU/mL |
| Menjugate/Infanrix-hexa Group | Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | 287.3 mIU/mL |
Secondary
Anti-poliovirus Types 1, 2, 3 Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
Time frame: One month after the third dose (at study Month 3 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Anti-poliovirus Types 1, 2, 3 Antibody Titres | Anti-poliovirus type 1 (N=57,55,56,61,56) | 275.5 Titers |
| Menhibrix F1/Infanrix-penta Group | Anti-poliovirus Types 1, 2, 3 Antibody Titres | Anti-poliovirus type 3 (N=57,55,58,61,56) | 649.0 Titers |
| Menhibrix F1/Infanrix-penta Group | Anti-poliovirus Types 1, 2, 3 Antibody Titres | Anti-poliovirus type 2 (N=55,55,58,61,56) | 155.8 Titers |
| Menhibrix F2/Infanrix-penta Group | Anti-poliovirus Types 1, 2, 3 Antibody Titres | Anti-poliovirus type 2 (N=55,55,58,61,56) | 149.9 Titers |
| Menhibrix F2/Infanrix-penta Group | Anti-poliovirus Types 1, 2, 3 Antibody Titres | Anti-poliovirus type 1 (N=57,55,56,61,56) | 242.0 Titers |
| Menhibrix F2/Infanrix-penta Group | Anti-poliovirus Types 1, 2, 3 Antibody Titres | Anti-poliovirus type 3 (N=57,55,58,61,56) | 577.2 Titers |
| Menhibrix F3/Infanrix-penta Group | Anti-poliovirus Types 1, 2, 3 Antibody Titres | Anti-poliovirus type 2 (N=55,55,58,61,56) | 133.7 Titers |
| Menhibrix F3/Infanrix-penta Group | Anti-poliovirus Types 1, 2, 3 Antibody Titres | Anti-poliovirus type 1 (N=57,55,56,61,56) | 216.8 Titers |
| Menhibrix F3/Infanrix-penta Group | Anti-poliovirus Types 1, 2, 3 Antibody Titres | Anti-poliovirus type 3 (N=57,55,58,61,56) | 451.7 Titers |
| Menitorix/Infanrix-penta Group | Anti-poliovirus Types 1, 2, 3 Antibody Titres | Anti-poliovirus type 1 (N=57,55,56,61,56) | 305.2 Titers |
| Menitorix/Infanrix-penta Group | Anti-poliovirus Types 1, 2, 3 Antibody Titres | Anti-poliovirus type 3 (N=57,55,58,61,56) | 603.6 Titers |
| Menitorix/Infanrix-penta Group | Anti-poliovirus Types 1, 2, 3 Antibody Titres | Anti-poliovirus type 2 (N=55,55,58,61,56) | 123.1 Titers |
| Menjugate/Infanrix-hexa Group | Anti-poliovirus Types 1, 2, 3 Antibody Titres | Anti-poliovirus type 2 (N=55,55,58,61,56) | 171.3 Titers |
| Menjugate/Infanrix-hexa Group | Anti-poliovirus Types 1, 2, 3 Antibody Titres | Anti-poliovirus type 1 (N=57,55,56,61,56) | 282.6 Titers |
| Menjugate/Infanrix-hexa Group | Anti-poliovirus Types 1, 2, 3 Antibody Titres | Anti-poliovirus type 3 (N=57,55,58,61,56) | 505.7 Titers |
Secondary
Anti-PRP Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Anti-PRP Antibody Concentrations | Anti-PRP [Month 0] (N=69,63,71,73,71) | 0.289 µg/mL |
| Menhibrix F1/Infanrix-penta Group | Anti-PRP Antibody Concentrations | Anti-PRP [Month 3] (N=67,67,70,74,71) | 9.014 µg/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-PRP Antibody Concentrations | Anti-PRP [Month 0] (N=69,63,71,73,71) | 0.243 µg/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-PRP Antibody Concentrations | Anti-PRP [Month 3] (N=67,67,70,74,71) | 9.485 µg/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-PRP Antibody Concentrations | Anti-PRP [Month 0] (N=69,63,71,73,71) | 0.255 µg/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-PRP Antibody Concentrations | Anti-PRP [Month 3] (N=67,67,70,74,71) | 8.075 µg/mL |
| Menitorix/Infanrix-penta Group | Anti-PRP Antibody Concentrations | Anti-PRP [Month 3] (N=67,67,70,74,71) | 10.435 µg/mL |
| Menitorix/Infanrix-penta Group | Anti-PRP Antibody Concentrations | Anti-PRP [Month 0] (N=69,63,71,73,71) | 0.243 µg/mL |
| Menjugate/Infanrix-hexa Group | Anti-PRP Antibody Concentrations | Anti-PRP [Month 0] (N=69,63,71,73,71) | 0.217 µg/mL |
| Menjugate/Infanrix-hexa Group | Anti-PRP Antibody Concentrations | Anti-PRP [Month 3] (N=67,67,70,74,71) | 2.595 µg/mL |
Secondary
Anti-PRP Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Anti-PRP Antibody Concentrations | Anti-PRP [Month 0] (N=41,39,42,42,36) | 1.306 µg/mL |
| Menhibrix F1/Infanrix-penta Group | Anti-PRP Antibody Concentrations | Anti-PRP [Month 1] (N=39,39,39,40,39) | 36.280 µg/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-PRP Antibody Concentrations | Anti-PRP [Month 0] (N=41,39,42,42,36) | 1.591 µg/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-PRP Antibody Concentrations | Anti-PRP [Month 1] (N=39,39,39,40,39) | 32.930 µg/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-PRP Antibody Concentrations | Anti-PRP [Month 0] (N=41,39,42,42,36) | 1.414 µg/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-PRP Antibody Concentrations | Anti-PRP [Month 1] (N=39,39,39,40,39) | 34.107 µg/mL |
| Menitorix/Infanrix-penta Group | Anti-PRP Antibody Concentrations | Anti-PRP [Month 1] (N=39,39,39,40,39) | 47.742 µg/mL |
| Menitorix/Infanrix-penta Group | Anti-PRP Antibody Concentrations | Anti-PRP [Month 0] (N=41,39,42,42,36) | 1.764 µg/mL |
| Menjugate/Infanrix-hexa Group | Anti-PRP Antibody Concentrations | Anti-PRP [Month 0] (N=41,39,42,42,36) | 0.607 µg/mL |
| Menjugate/Infanrix-hexa Group | Anti-PRP Antibody Concentrations | Anti-PRP [Month 1] (N=39,39,39,40,39) | 24.345 µg/mL |
Secondary
Anti-PSC Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Anti-PSC Antibody Concentrations | Anti-PSC [Month 0] (N=38,38,40,40,38) | 2.57 µg/mL |
| Menhibrix F1/Infanrix-penta Group | Anti-PSC Antibody Concentrations | Anti-PSC [Month 1] (N=33,33,39,37,39) | 32.04 µg/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-PSC Antibody Concentrations | Anti-PSC [Month 0] (N=38,38,40,40,38) | 3.23 µg/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-PSC Antibody Concentrations | Anti-PSC [Month 1] (N=33,33,39,37,39) | 28.00 µg/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-PSC Antibody Concentrations | Anti-PSC [Month 0] (N=38,38,40,40,38) | 2.53 µg/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-PSC Antibody Concentrations | Anti-PSC [Month 1] (N=33,33,39,37,39) | 19.75 µg/mL |
| Menitorix/Infanrix-penta Group | Anti-PSC Antibody Concentrations | Anti-PSC [Month 1] (N=33,33,39,37,39) | 27.71 µg/mL |
| Menitorix/Infanrix-penta Group | Anti-PSC Antibody Concentrations | Anti-PSC [Month 0] (N=38,38,40,40,38) | 3.08 µg/mL |
| Menjugate/Infanrix-hexa Group | Anti-PSC Antibody Concentrations | Anti-PSC [Month 0] (N=38,38,40,40,38) | 3.17 µg/mL |
| Menjugate/Infanrix-hexa Group | Anti-PSC Antibody Concentrations | Anti-PSC [Month 1] (N=33,33,39,37,39) | 64.41 µg/mL |
Secondary
Anti-PSC Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Anti-PSC Antibody Concentrations | Anti-PSC [Month 0] (N=69,63,71,74,71) | 0.18 µg/mL |
| Menhibrix F1/Infanrix-penta Group | Anti-PSC Antibody Concentrations | Anti-PSC [Month 3] (N=69,66,70,74,71) | 21.70 µg/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-PSC Antibody Concentrations | Anti-PSC [Month 0] (N=69,63,71,74,71) | 0.20 µg/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-PSC Antibody Concentrations | Anti-PSC [Month 3] (N=69,66,70,74,71) | 27.26 µg/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-PSC Antibody Concentrations | Anti-PSC [Month 0] (N=69,63,71,74,71) | 0.18 µg/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-PSC Antibody Concentrations | Anti-PSC [Month 3] (N=69,66,70,74,71) | 19.02 µg/mL |
| Menitorix/Infanrix-penta Group | Anti-PSC Antibody Concentrations | Anti-PSC [Month 3] (N=69,66,70,74,71) | 21.08 µg/mL |
| Menitorix/Infanrix-penta Group | Anti-PSC Antibody Concentrations | Anti-PSC [Month 0] (N=69,63,71,74,71) | 0.18 µg/mL |
| Menjugate/Infanrix-hexa Group | Anti-PSC Antibody Concentrations | Anti-PSC [Month 0] (N=69,63,71,74,71) | 0.18 µg/mL |
| Menjugate/Infanrix-hexa Group | Anti-PSC Antibody Concentrations | Anti-PSC [Month 3] (N=69,66,70,74,71) | 38.49 µg/mL |
Secondary
Anti-PSY Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Anti-PSY Antibody Concentrations | Anti-PSY [Month 0] (N=39,39,42,42,38) | 3.72 µg/mL |
| Menhibrix F1/Infanrix-penta Group | Anti-PSY Antibody Concentrations | Anti-PSY [Month 1] (N=42,39,41,40,38) | 26.15 µg/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-PSY Antibody Concentrations | Anti-PSY [Month 0] (N=39,39,42,42,38) | 5.25 µg/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-PSY Antibody Concentrations | Anti-PSY [Month 1] (N=42,39,41,40,38) | 35.90 µg/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-PSY Antibody Concentrations | Anti-PSY [Month 0] (N=39,39,42,42,38) | 3.96 µg/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-PSY Antibody Concentrations | Anti-PSY [Month 1] (N=42,39,41,40,38) | 32.18 µg/mL |
| Menitorix/Infanrix-penta Group | Anti-PSY Antibody Concentrations | Anti-PSY [Month 1] (N=42,39,41,40,38) | 0.17 µg/mL |
| Menitorix/Infanrix-penta Group | Anti-PSY Antibody Concentrations | Anti-PSY [Month 0] (N=39,39,42,42,38) | 0.16 µg/mL |
| Menjugate/Infanrix-hexa Group | Anti-PSY Antibody Concentrations | Anti-PSY [Month 0] (N=39,39,42,42,38) | NA µg/mL |
| Menjugate/Infanrix-hexa Group | Anti-PSY Antibody Concentrations | Anti-PSY [Month 1] (N=42,39,41,40,38) | NA µg/mL |
Secondary
Anti-PSY Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Anti-PSY Antibody Concentrations | Anti-PSY [Month 0] (N=69,64,71,73,71) | 0.19 µg/mL |
| Menhibrix F1/Infanrix-penta Group | Anti-PSY Antibody Concentrations | Anti-PSY [Month 3] (N=69,66,70,74,71) | 26.86 µg/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-PSY Antibody Concentrations | Anti-PSY [Month 0] (N=69,64,71,73,71) | 0.18 µg/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-PSY Antibody Concentrations | Anti-PSY [Month 3] (N=69,66,70,74,71) | 37.02 µg/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-PSY Antibody Concentrations | Anti-PSY [Month 0] (N=69,64,71,73,71) | 0.20 µg/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-PSY Antibody Concentrations | Anti-PSY [Month 3] (N=69,66,70,74,71) | 23.57 µg/mL |
| Menitorix/Infanrix-penta Group | Anti-PSY Antibody Concentrations | Anti-PSY [Month 3] (N=69,66,70,74,71) | 0.19 µg/mL |
| Menitorix/Infanrix-penta Group | Anti-PSY Antibody Concentrations | Anti-PSY [Month 0] (N=69,64,71,73,71) | 0.22 µg/mL |
| Menjugate/Infanrix-hexa Group | Anti-PSY Antibody Concentrations | Anti-PSY [Month 0] (N=69,64,71,73,71) | 0.20 µg/mL |
| Menjugate/Infanrix-hexa Group | Anti-PSY Antibody Concentrations | Anti-PSY [Month 3] (N=69,66,70,74,71) | 0.17 µg/mL |
Secondary
Anti-T Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Anti-T Antibody Concentrations | Anti-tetanus [Month 1] (N=39,39,39,40,39) | 12.609 IU/mL |
| Menhibrix F1/Infanrix-penta Group | Anti-T Antibody Concentrations | Anti-tetanus [Month 0] (N=41,39,42,42,38) | 0.836 IU/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-T Antibody Concentrations | Anti-tetanus [Month 1] (N=39,39,39,40,39) | 10.175 IU/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-T Antibody Concentrations | Anti-tetanus [Month 0] (N=41,39,42,42,38) | 0.986 IU/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-T Antibody Concentrations | Anti-tetanus [Month 0] (N=41,39,42,42,38) | 0.894 IU/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-T Antibody Concentrations | Anti-tetanus [Month 1] (N=39,39,39,40,39) | 9.893 IU/mL |
| Menitorix/Infanrix-penta Group | Anti-T Antibody Concentrations | Anti-tetanus [Month 0] (N=41,39,42,42,38) | 0.839 IU/mL |
| Menitorix/Infanrix-penta Group | Anti-T Antibody Concentrations | Anti-tetanus [Month 1] (N=39,39,39,40,39) | 11.674 IU/mL |
| Menjugate/Infanrix-hexa Group | Anti-T Antibody Concentrations | Anti-tetanus [Month 0] (N=41,39,42,42,38) | 0.322 IU/mL |
| Menjugate/Infanrix-hexa Group | Anti-T Antibody Concentrations | Anti-tetanus [Month 1] (N=39,39,39,40,39) | 5.474 IU/mL |
Secondary
Anti-tetanus Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Anti-tetanus Antibody Concentrations | Anti-tetanus [Month 0] (N=69,63,71,73,71) | 0.433 IU/mL |
| Menhibrix F1/Infanrix-penta Group | Anti-tetanus Antibody Concentrations | Anti-tetanus [Month 3] (N=68,67,70,74,71) | 3.057 IU/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-tetanus Antibody Concentrations | Anti-tetanus [Month 0] (N=69,63,71,73,71) | 0.485 IU/mL |
| Menhibrix F2/Infanrix-penta Group | Anti-tetanus Antibody Concentrations | Anti-tetanus [Month 3] (N=68,67,70,74,71) | 3.254 IU/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-tetanus Antibody Concentrations | Anti-tetanus [Month 0] (N=69,63,71,73,71) | 0.523 IU/mL |
| Menhibrix F3/Infanrix-penta Group | Anti-tetanus Antibody Concentrations | Anti-tetanus [Month 3] (N=68,67,70,74,71) | 2.972 IU/mL |
| Menitorix/Infanrix-penta Group | Anti-tetanus Antibody Concentrations | Anti-tetanus [Month 3] (N=68,67,70,74,71) | 3.151 IU/mL |
| Menitorix/Infanrix-penta Group | Anti-tetanus Antibody Concentrations | Anti-tetanus [Month 0] (N=69,63,71,73,71) | 0.436 IU/mL |
| Menjugate/Infanrix-hexa Group | Anti-tetanus Antibody Concentrations | Anti-tetanus [Month 0] (N=69,63,71,73,71) | 0.379 IU/mL |
| Menjugate/Infanrix-hexa Group | Anti-tetanus Antibody Concentrations | Anti-tetanus [Month 3] (N=68,67,70,74,71) | 1.656 IU/mL |
Secondary
Number of Seroprotected Subjects for Anti-diphtheria Antibodies
Seroprotection status is defined as anti-diphtheria antibody concentrations ≥ 0.1 IU/mL
Time frame: One month after the third dose (at study Month 3 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-diphtheria Antibodies | 66 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-diphtheria Antibodies | 64 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-diphtheria Antibodies | 69 Subjects |
| Menitorix/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-diphtheria Antibodies | 74 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Seroprotected Subjects for Anti-diphtheria Antibodies | 69 Subjects |
Secondary
Number of Seroprotected Subjects for Anti-hepatitis B Antibodies
Seroprotection status is defined as anti-HBs antibody concentrations ≥ 10 mIU/mL
Time frame: One month after the third dose (at study Month 3 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-hepatitis B Antibodies | 60 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-hepatitis B Antibodies | 60 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-hepatitis B Antibodies | 66 Subjects |
| Menitorix/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-hepatitis B Antibodies | 70 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Seroprotected Subjects for Anti-hepatitis B Antibodies | 61 Subjects |
Secondary
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies
Seroprotection status is defined as anti-polio 1, 2 and 3 antibody titres ≥ 1:8
Time frame: One month after the third dose (at study Month 3 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies | Anti-poliovirus type 1 (N=57,55,56,61,56) | 57 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies | Anti-poliovirus type 3 (N=57,55,58,61,56) | 57 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies | Anti-poliovirus type 2 (N=55,55,58,61,56) | 55 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies | Anti-poliovirus type 2 (N=55,55,58,61,56) | 55 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies | Anti-poliovirus type 1 (N=57,55,56,61,56) | 55 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies | Anti-poliovirus type 3 (N=57,55,58,61,56) | 55 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies | Anti-poliovirus type 2 (N=55,55,58,61,56) | 58 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies | Anti-poliovirus type 1 (N=57,55,56,61,56) | 56 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies | Anti-poliovirus type 3 (N=57,55,58,61,56) | 58 Subjects |
| Menitorix/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies | Anti-poliovirus type 1 (N=57,55,56,61,56) | 61 Subjects |
| Menitorix/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies | Anti-poliovirus type 3 (N=57,55,58,61,56) | 61 Subjects |
| Menitorix/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies | Anti-poliovirus type 2 (N=55,55,58,61,56) | 59 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies | Anti-poliovirus type 2 (N=55,55,58,61,56) | 56 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies | Anti-poliovirus type 1 (N=57,55,56,61,56) | 55 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies | Anti-poliovirus type 3 (N=57,55,58,61,56) | 56 Subjects |
Secondary
Number of Seroprotected Subjects for Anti-tetanus Antibodies
Seroprotection status is defined as anti-tetanus toxoid antibody concentration ≥ 0.1 International Units per millilitre (IU/mL)
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-tetanus Antibodies | Anti-tetanus [Month 0] (N=69,63,71,73,71) | 58 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-tetanus Antibodies | Anti-tetanus [Month 3] (N=68,67,70,74,71) | 68 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-tetanus Antibodies | Anti-tetanus [Month 0] (N=69,63,71,73,71) | 57 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-tetanus Antibodies | Anti-tetanus [Month 3] (N=68,67,70,74,71) | 67 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-tetanus Antibodies | Anti-tetanus [Month 0] (N=69,63,71,73,71) | 60 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-tetanus Antibodies | Anti-tetanus [Month 3] (N=68,67,70,74,71) | 70 Subjects |
| Menitorix/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-tetanus Antibodies | Anti-tetanus [Month 3] (N=68,67,70,74,71) | 74 Subjects |
| Menitorix/Infanrix-penta Group | Number of Seroprotected Subjects for Anti-tetanus Antibodies | Anti-tetanus [Month 0] (N=69,63,71,73,71) | 63 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Seroprotected Subjects for Anti-tetanus Antibodies | Anti-tetanus [Month 0] (N=69,63,71,73,71) | 61 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Seroprotected Subjects for Anti-tetanus Antibodies | Anti-tetanus [Month 3] (N=68,67,70,74,71) | 71 Subjects |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time frame: Over the full course of the primary phase (up to study Month 3 - primary phase)
Population: The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 0 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 1 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 2 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 1 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 3 Subjects |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time frame: Over the full course of the booster phase (up to study Month 1 - booster phase)
Population: The Booster Total Vaccinated Cohort included all subjects who received the booster dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 1 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 1 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 0 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 1 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 0 Subjects |
Secondary
Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL)
Anti-FHA, anti-PRN and anti-PT antibody concentration cut-off value assessed was ≥ 5 ELISA units per millilitre.
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-PT [Month 0] (N=67,62,68,70,69) | 15 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-PT [Month 3] (N=67,63,69,74,69) | 67 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-FHA [Month 0] (N=69,63,69,72,70) | 42 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-FHA [Month 3] (N=67,63,69,74,71) | 67 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-PRN [Month 0] (N=68,62,71,72,70) | 36 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-PRN [Month 3] (N=68,67,70,74,71) | 68 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-PRN [Month 0] (N=68,62,71,72,70) | 25 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-PRN [Month 3] (N=68,67,70,74,71) | 67 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-PT [Month 0] (N=67,62,68,70,69) | 11 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-FHA [Month 0] (N=69,63,69,72,70) | 37 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-FHA [Month 3] (N=67,63,69,74,71) | 63 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-PT [Month 3] (N=67,63,69,74,69) | 63 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-FHA [Month 3] (N=67,63,69,74,71) | 69 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-PRN [Month 0] (N=68,62,71,72,70) | 37 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-PT [Month 0] (N=67,62,68,70,69) | 18 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-FHA [Month 0] (N=69,63,69,72,70) | 42 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-PT [Month 3] (N=67,63,69,74,69) | 69 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-PRN [Month 3] (N=68,67,70,74,71) | 70 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-FHA [Month 3] (N=67,63,69,74,71) | 74 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-PT [Month 3] (N=67,63,69,74,69) | 74 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-FHA [Month 0] (N=69,63,69,72,70) | 55 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-PRN [Month 3] (N=68,67,70,74,71) | 74 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-PRN [Month 0] (N=68,62,71,72,70) | 37 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-PT [Month 0] (N=67,62,68,70,69) | 12 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-PRN [Month 0] (N=68,62,71,72,70) | 37 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-FHA [Month 0] (N=69,63,69,72,70) | 45 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-PT [Month 3] (N=67,63,69,74,69) | 69 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-PRN [Month 3] (N=68,67,70,74,71) | 71 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-FHA [Month 3] (N=67,63,69,74,71) | 71 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) | Anti-PT [Month 0] (N=67,62,68,70,69) | 9 Subjects |
Secondary
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). | Anti-PRP >= 0.15 µg/mL Month 0 (N=41,39,42,42,36) | 39 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). | Anti-PRP >= 0.15 µg/mL Month 1 (N=39,39,39,40,39) | 39 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). | Anti-PRP >= 0.15 µg/mL Month 0 (N=41,39,42,42,36) | 38 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). | Anti-PRP >= 0.15 µg/mL Month 1 (N=39,39,39,40,39) | 39 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). | Anti-PRP >= 0.15 µg/mL Month 0 (N=41,39,42,42,36) | 42 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). | Anti-PRP >= 0.15 µg/mL Month 1 (N=39,39,39,40,39) | 39 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). | Anti-PRP >= 0.15 µg/mL Month 1 (N=39,39,39,40,39) | 40 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). | Anti-PRP >= 0.15 µg/mL Month 0 (N=41,39,42,42,36) | 42 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). | Anti-PRP >= 0.15 µg/mL Month 0 (N=41,39,42,42,36) | 36 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). | Anti-PRP >= 0.15 µg/mL Month 1 (N=39,39,39,40,39) | 39 Subjects |
Secondary
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). | Anti-PRP >= 0.15 µg/mL [Mth 0] (N=69,63,71,73,71) | 51 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). | Anti-PRP >= 0.15 µg/mL [Mth 3] (N=67,67,70,74,71) | 67 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). | Anti-PRP >= 0.15 µg/mL [Mth 0] (N=69,63,71,73,71) | 42 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). | Anti-PRP >= 0.15 µg/mL [Mth 3] (N=67,67,70,74,71) | 67 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). | Anti-PRP >= 0.15 µg/mL [Mth 0] (N=69,63,71,73,71) | 50 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). | Anti-PRP >= 0.15 µg/mL [Mth 3] (N=67,67,70,74,71) | 70 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). | Anti-PRP >= 0.15 µg/mL [Mth 3] (N=67,67,70,74,71) | 74 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). | Anti-PRP >= 0.15 µg/mL [Mth 0] (N=69,63,71,73,71) | 50 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). | Anti-PRP >= 0.15 µg/mL [Mth 0] (N=69,63,71,73,71) | 50 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). | Anti-PRP >= 0.15 µg/mL [Mth 3] (N=67,67,70,74,71) | 71 Subjects |
Secondary
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
Time frame: Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). | 13 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). | 8 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). | 8 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). | 9 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). | 3 Subjects |
Secondary
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
Time frame: Prior to the booster vaccination (at study Month 0 - booster phase)
Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). | 26 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). | 28 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). | 27 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). | 32 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). | 11 Subjects |
Secondary
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)
Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 0] (N=69,63,71,74,71) | 7 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 3] (N=69,66,70,74,71) | 69 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 0] (N=69,63,71,74,71) | 12 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 3] (N=69,66,70,74,71) | 66 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 0] (N=69,63,71,74,71) | 7 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 3] (N=69,66,70,74,71) | 70 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 3] (N=69,66,70,74,71) | 74 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 0] (N=69,63,71,74,71) | 7 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 0] (N=69,63,71,74,71) | 10 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 3] (N=69,66,70,74,71) | 71 Subjects |
Secondary
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)
Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 0] (N=38,38,40,40,38) | 38 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 1] (N=33,33,39,37,39) | 33 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 0] (N=38,38,40,40,38) | 38 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 1] (N=33,33,39,37,39) | 33 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 0] (N=38,38,40,40,38) | 40 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 1] (N=33,33,39,37,39) | 39 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 1] (N=33,33,39,37,39) | 37 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 0] (N=38,38,40,40,38) | 40 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 0] (N=38,38,40,40,38) | 38 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 1] (N=33,33,39,37,39) | 39 Subjects |
Secondary
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL)
Anti-PSC antibody concentration cut-off value assessed was ≥2.0 µg/mL
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 0] (N=38,38,40,40,38) | 24 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 1] (N=33,33,39,37,39) | 33 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 0] (N=38,38,40,40,38) | 30 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 1] (N=33,33,39,37,39) | 33 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 0] (N=38,38,40,40,38) | 28 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 1] (N=33,33,39,37,39) | 39 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 1] (N=33,33,39,37,39) | 37 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 0] (N=38,38,40,40,38) | 26 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 0] (N=38,38,40,40,38) | 27 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL) | Anti-PSC [Month 1] (N=33,33,39,37,39) | 39 Subjects |
Secondary
Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)
Anti-PSY antibody concentration cut-off value assessed was ≥0.30 µg/mL
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSY [Month 0] (N=69,64,71,73,71) | 7 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSY [Month 3] (N=69,66,70,74,71) | 69 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSY [Month 0] (N=69,64,71,73,71) | 6 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSY [Month 3] (N=69,66,70,74,71) | 66 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSY [Month 0] (N=69,64,71,73,71) | 12 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSY [Month 3] (N=69,66,70,74,71) | 70 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSY [Month 3] (N=69,66,70,74,71) | 6 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSY [Month 0] (N=69,64,71,73,71) | 15 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSY [Month 0] (N=69,64,71,73,71) | 12 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) | Anti-PSY [Month 3] (N=69,66,70,74,71) | 4 Subjects |
Secondary
Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL).
Anti-tetanus toxoid antibody concentration cut-off value assessed was ≥ 0.1 IU/mL
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL). | Anti-tetanus [Month 0] (N=41,39,42,42,38) | 41 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL). | Anti-tetanus [Month 1] (N=39,39,39,40,39) | 39 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL). | Anti-tetanus [Month 0] (N=41,39,42,42,38) | 39 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL). | Anti-tetanus [Month 1] (N=39,39,39,40,39) | 39 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL). | Anti-tetanus [Month 0] (N=41,39,42,42,38) | 42 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL). | Anti-tetanus [Month 1] (N=39,39,39,40,39) | 39 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL). | Anti-tetanus [Month 1] (N=39,39,39,40,39) | 40 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL). | Anti-tetanus [Month 0] (N=41,39,42,42,38) | 42 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL). | Anti-tetanus [Month 0] (N=41,39,42,42,38) | 37 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL). | Anti-tetanus [Month 1] (N=39,39,39,40,39) | 39 Subjects |
Secondary
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128
rSBA-MenC antibody titre cut-off value assessed was ≥1:128
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128 | rSBA-Menc [Month 0] (N=42,39,41,41,38) | 25 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128 | rSBA-Menc [Month 1] (N=40,39,42,41,39) | 40 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128 | rSBA-Menc [Month 0] (N=42,39,41,41,38) | 24 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128 | rSBA-Menc [Month 1] (N=40,39,42,41,39) | 36 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128 | rSBA-Menc [Month 0] (N=42,39,41,41,38) | 22 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128 | rSBA-Menc [Month 1] (N=40,39,42,41,39) | 42 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128 | rSBA-Menc [Month 1] (N=40,39,42,41,39) | 40 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128 | rSBA-Menc [Month 0] (N=42,39,41,41,38) | 27 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128 | rSBA-Menc [Month 0] (N=42,39,41,41,38) | 26 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128 | rSBA-Menc [Month 1] (N=40,39,42,41,39) | 39 Subjects |
Secondary
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
Time frame: Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 | 4 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 | 6 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 | 4 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 | 6 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 | 3 Subjects |
Secondary
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
Time frame: Prior to the booster vaccination (at study Month 0 - booster phase)
Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 | 38 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 | 38 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 | 38 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 | 39 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 | 36 Subjects |
Secondary
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128
rSBA-MenY antibody titre cut-off value assessed was ≥1:128
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128 | rSBA-MenY [Month 0] (N=41,39,42,42,37) | 24 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128 | rSBA-MenY [Month 1] (N=40,39,42,40,39) | 40 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128 | rSBA-MenY [Month 0] (N=41,39,42,42,37) | 18 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128 | rSBA-MenY [Month 1] (N=40,39,42,40,39) | 39 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128 | rSBA-MenY [Month 0] (N=41,39,42,42,37) | 23 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128 | rSBA-MenY [Month 1] (N=40,39,42,40,39) | 42 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128 | rSBA-MenY [Month 1] (N=40,39,42,40,39) | 6 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128 | rSBA-MenY [Month 0] (N=41,39,42,42,37) | 6 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128 | rSBA-MenY [Month 0] (N=41,39,42,42,37) | 7 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128 | rSBA-MenY [Month 1] (N=40,39,42,40,39) | 10 Subjects |
Secondary
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
Time frame: Prior to the booster vaccination (at study Month 0 - booster phase)
Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 | 35 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 | 31 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 | 36 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 | 11 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 | 15 Subjects |
Secondary
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
Time frame: Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 | 11 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 | 10 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 | 16 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 | 10 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 | 17 Subjects |
Secondary
Number of Subjects With Solicited General Symptoms
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).
Time frame: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Population: The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Drowsiness | 39 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Irritability | 44 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Loss of appetite | 24 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Fever (rectal) >= 38.0°C | 25 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Drowsiness | 53 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Fever (rectal) >= 38.0°C | 28 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Irritability | 42 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Loss of appetite | 34 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Fever (rectal) >= 38.0°C | 26 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Irritability | 51 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Loss of appetite | 29 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Drowsiness | 43 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Drowsiness | 37 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Irritability | 47 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Fever (rectal) >= 38.0°C | 28 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Loss of appetite | 33 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Solicited General Symptoms | Fever (rectal) >= 38.0°C | 28 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Solicited General Symptoms | Loss of appetite | 30 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Solicited General Symptoms | Irritability | 44 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Solicited General Symptoms | Drowsiness | 46 Subjects |
Secondary
Number of Subjects With Solicited General Symptoms
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).
Time frame: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Population: The Booster Total Vaccinated Cohort included all subjects who received the booster dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Drowsiness | 14 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Irritability | 16 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Loss of appetite | 11 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Fever (rectal) >= 38.0°C | 13 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Drowsiness | 18 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Fever (rectal) >= 38.0°C | 10 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Irritability | 18 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Loss of appetite | 16 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Fever (rectal) >= 38.0°C | 16 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Irritability | 19 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Loss of appetite | 12 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Drowsiness | 18 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Drowsiness | 17 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Irritability | 14 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Fever (rectal) >= 38.0°C | 18 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Solicited General Symptoms | Loss of appetite | 10 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Solicited General Symptoms | Fever (rectal) >= 38.0°C | 16 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Solicited General Symptoms | Loss of appetite | 14 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Solicited General Symptoms | Irritability | 17 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Solicited General Symptoms | Drowsiness | 18 Subjects |
Secondary
Number of Subjects With Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling.
Time frame: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Population: The Booster Total Vaccinated Cohort included all subjects who received the booster dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Redness | 20 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Pain | 5 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Swelling | 15 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Pain | 10 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Swelling | 12 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Redness | 18 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Pain | 8 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Redness | 22 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Swelling | 12 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Swelling | 9 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Pain | 8 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Redness | 16 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Solicited Local Symptoms | Redness | 16 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Solicited Local Symptoms | Pain | 9 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Solicited Local Symptoms | Swelling | 10 Subjects |
Secondary
Number of Subjects With Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling.
Time frame: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Population: The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Pain | 21 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Swelling | 31 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Redness | 35 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Redness | 38 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Pain | 20 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Swelling | 35 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Redness | 50 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Pain | 22 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Swelling | 30 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Pain | 19 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Swelling | 27 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Solicited Local Symptoms | Redness | 32 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Solicited Local Symptoms | Redness | 46 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Solicited Local Symptoms | Pain | 19 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Solicited Local Symptoms | Swelling | 35 Subjects |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Population: The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 39 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 33 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 35 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 31 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 26 Subjects |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: During the 31-day (Day 0-30) follow-up period (during the booster phase)
Population: The Booster Total Vaccinated Cohort included all subjects who received the booster dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 7 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 12 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 13 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 12 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 11 Subjects |
Secondary
Number of Subjects With Vaccine Response to PT, FHA and PRN
Vaccine response rates are defined as appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations \< cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.
Time frame: One month after the third dose (at study Month 3 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Vaccine Response to PT, FHA and PRN | Anti-PT (N=64,58,66,70,68) | 63 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Vaccine Response to PT, FHA and PRN | Anti-PRN (N=66,62,70,72,70) | 61 Subjects |
| Menhibrix F1/Infanrix-penta Group | Number of Subjects With Vaccine Response to PT, FHA and PRN | Anti-FHA (N=66,59,67,72,70) | 65 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Vaccine Response to PT, FHA and PRN | Anti-FHA (N=66,59,67,72,70) | 58 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Vaccine Response to PT, FHA and PRN | Anti-PT (N=64,58,66,70,68) | 58 Subjects |
| Menhibrix F2/Infanrix-penta Group | Number of Subjects With Vaccine Response to PT, FHA and PRN | Anti-PRN (N=66,62,70,72,70) | 59 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Vaccine Response to PT, FHA and PRN | Anti-FHA (N=66,59,67,72,70) | 65 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Vaccine Response to PT, FHA and PRN | Anti-PT (N=64,58,66,70,68) | 64 Subjects |
| Menhibrix F3/Infanrix-penta Group | Number of Subjects With Vaccine Response to PT, FHA and PRN | Anti-PRN (N=66,62,70,72,70) | 68 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Vaccine Response to PT, FHA and PRN | Anti-PT (N=64,58,66,70,68) | 66 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Vaccine Response to PT, FHA and PRN | Anti-PRN (N=66,62,70,72,70) | 63 Subjects |
| Menitorix/Infanrix-penta Group | Number of Subjects With Vaccine Response to PT, FHA and PRN | Anti-FHA (N=66,59,67,72,70) | 68 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Vaccine Response to PT, FHA and PRN | Anti-FHA (N=66,59,67,72,70) | 70 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Vaccine Response to PT, FHA and PRN | Anti-PT (N=64,58,66,70,68) | 68 Subjects |
| Menjugate/Infanrix-hexa Group | Number of Subjects With Vaccine Response to PT, FHA and PRN | Anti-PRN (N=66,62,70,72,70) | 65 Subjects |
Secondary
rSBA-MenC Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | rSBA-MenC Antibody Titres | rSBA-MenC [Month 0] (N=42,39,41,41,38) | 128.0 Titers |
| Menhibrix F1/Infanrix-penta Group | rSBA-MenC Antibody Titres | rSBA-MenC [Month 1] (N=40,39,42,41,39) | 4762.6 Titers |
| Menhibrix F2/Infanrix-penta Group | rSBA-MenC Antibody Titres | rSBA-MenC [Month 0] (N=42,39,41,41,38) | 144.2 Titers |
| Menhibrix F2/Infanrix-penta Group | rSBA-MenC Antibody Titres | rSBA-MenC [Month 1] (N=40,39,42,41,39) | 2897.7 Titers |
| Menhibrix F3/Infanrix-penta Group | rSBA-MenC Antibody Titres | rSBA-MenC [Month 0] (N=42,39,41,41,38) | 125.8 Titers |
| Menhibrix F3/Infanrix-penta Group | rSBA-MenC Antibody Titres | rSBA-MenC [Month 1] (N=40,39,42,41,39) | 2626.4 Titers |
| Menitorix/Infanrix-penta Group | rSBA-MenC Antibody Titres | rSBA-MenC [Month 1] (N=40,39,42,41,39) | 3226.2 Titers |
| Menitorix/Infanrix-penta Group | rSBA-MenC Antibody Titres | rSBA-MenC [Month 0] (N=42,39,41,41,38) | 150.6 Titers |
| Menjugate/Infanrix-hexa Group | rSBA-MenC Antibody Titres | rSBA-MenC [Month 0] (N=42,39,41,41,38) | 195.5 Titers |
| Menjugate/Infanrix-hexa Group | rSBA-MenC Antibody Titres | rSBA-MenC [Month 1] (N=40,39,42,41,39) | 11819.3 Titers |
Secondary
rSBA-MenC Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | rSBA-MenC Antibody Titres | rSBA-MenC [Month 0] (N=69,64,70,73,71) | 4.7 Titers |
| Menhibrix F1/Infanrix-penta Group | rSBA-MenC Antibody Titres | rSBA-MenC [Month 3] (N=70,67,71,74,71) | 1005.8 Titers |
| Menhibrix F2/Infanrix-penta Group | rSBA-MenC Antibody Titres | rSBA-MenC [Month 0] (N=69,64,70,73,71) | 4.8 Titers |
| Menhibrix F2/Infanrix-penta Group | rSBA-MenC Antibody Titres | rSBA-MenC [Month 3] (N=70,67,71,74,71) | 1029.8 Titers |
| Menhibrix F3/Infanrix-penta Group | rSBA-MenC Antibody Titres | rSBA-MenC [Month 0] (N=69,64,70,73,71) | 4.6 Titers |
| Menhibrix F3/Infanrix-penta Group | rSBA-MenC Antibody Titres | rSBA-MenC [Month 3] (N=70,67,71,74,71) | 906.9 Titers |
| Menitorix/Infanrix-penta Group | rSBA-MenC Antibody Titres | rSBA-MenC [Month 3] (N=70,67,71,74,71) | 871.0 Titers |
| Menitorix/Infanrix-penta Group | rSBA-MenC Antibody Titres | rSBA-MenC [Month 0] (N=69,64,70,73,71) | 4.7 Titers |
| Menjugate/Infanrix-hexa Group | rSBA-MenC Antibody Titres | rSBA-MenC [Month 0] (N=69,64,70,73,71) | 4.5 Titers |
| Menjugate/Infanrix-hexa Group | rSBA-MenC Antibody Titres | rSBA-MenC [Month 3] (N=70,67,71,74,71) | 3557.6 Titers |
Secondary
rSBA-MenY Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | rSBA-MenY Antibody Titres | rSBA-MenY [Month 0] (N=70,63,71,73,71) | 5.9 Titers |
| Menhibrix F1/Infanrix-penta Group | rSBA-MenY Antibody Titres | rSBA-MenY [Month 3] (N=69,66,71,74,71) | 470.7 Titers |
| Menhibrix F2/Infanrix-penta Group | rSBA-MenY Antibody Titres | rSBA-MenY [Month 0] (N=70,63,71,73,71) | 5.9 Titers |
| Menhibrix F2/Infanrix-penta Group | rSBA-MenY Antibody Titres | rSBA-MenY [Month 3] (N=69,66,71,74,71) | 437.1 Titers |
| Menhibrix F3/Infanrix-penta Group | rSBA-MenY Antibody Titres | rSBA-MenY [Month 0] (N=70,63,71,73,71) | 7.4 Titers |
| Menhibrix F3/Infanrix-penta Group | rSBA-MenY Antibody Titres | rSBA-MenY [Month 3] (N=69,66,71,74,71) | 635.3 Titers |
| Menitorix/Infanrix-penta Group | rSBA-MenY Antibody Titres | rSBA-MenY [Month 3] (N=69,66,71,74,71) | 9.3 Titers |
| Menitorix/Infanrix-penta Group | rSBA-MenY Antibody Titres | rSBA-MenY [Month 0] (N=70,63,71,73,71) | 5.9 Titers |
| Menjugate/Infanrix-hexa Group | rSBA-MenY Antibody Titres | rSBA-MenY [Month 0] (N=70,63,71,73,71) | 7.7 Titers |
| Menjugate/Infanrix-hexa Group | rSBA-MenY Antibody Titres | rSBA-MenY [Month 3] (N=69,66,71,74,71) | 7.5 Titers |
Secondary
rSBA-MenY Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix F1/Infanrix-penta Group | rSBA-MenY Antibody Titres | rSBA-MenY [Month 0] (N=41,39,42,42,37) | 97.2 Titres |
| Menhibrix F1/Infanrix-penta Group | rSBA-MenY Antibody Titres | rSBA-MenY [Month 1] (N=40,39,42,40,39) | 1708.1 Titres |
| Menhibrix F2/Infanrix-penta Group | rSBA-MenY Antibody Titres | rSBA-MenY [Month 0] (N=41,39,42,42,37) | 64.0 Titres |
| Menhibrix F2/Infanrix-penta Group | rSBA-MenY Antibody Titres | rSBA-MenY [Month 1] (N=40,39,42,40,39) | 1313.8 Titres |
| Menhibrix F3/Infanrix-penta Group | rSBA-MenY Antibody Titres | rSBA-MenY [Month 0] (N=41,39,42,42,37) | 100.9 Titres |
| Menhibrix F3/Infanrix-penta Group | rSBA-MenY Antibody Titres | rSBA-MenY [Month 1] (N=40,39,42,40,39) | 1566.0 Titres |
| Menitorix/Infanrix-penta Group | rSBA-MenY Antibody Titres | rSBA-MenY [Month 1] (N=40,39,42,40,39) | 11.7 Titres |
| Menitorix/Infanrix-penta Group | rSBA-MenY Antibody Titres | rSBA-MenY [Month 0] (N=41,39,42,42,37) | 11.0 Titres |
| Menjugate/Infanrix-hexa Group | rSBA-MenY Antibody Titres | rSBA-MenY [Month 0] (N=41,39,42,42,37) | 16.1 Titres |
| Menjugate/Infanrix-hexa Group | rSBA-MenY Antibody Titres | rSBA-MenY [Month 1] (N=40,39,42,40,39) | 16.5 Titres |